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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K252758
Device Name Cannulated Screw and Kirschner (K wire) System
Applicant
Orthonovis, Inc.
1 Hargrove Grade
Suite 2f
Palm Coast,  FL  32137
Applicant Contact Ken West
Correspondent
Simple Path, LLC
712 Lyndhurst St.
Unit 321
Dunedin,  FL  34698
Correspondent Contact Tawney Schwarz
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTN   HTY  
Date Received08/29/2025
Decision Date 10/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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